1. Field of the Invention
This invention involves a disposable device, manufactured by use of a rubber or elastomer matrix, which contains an active ingredient that will slowly permeate out and into the mouth. The device is quickly and easily placed into the mouth, where it is held in a fixed position between two teeth in an unobtrusive manner, and can be quickly removed.
There is a need for devices that will provide slow and controlled release of functional materials or substances within the body of humans and animals. Simple and obvious examples of this need are the chewing gum products, which contain various substances such as peppermint or spearmint odorants to provide a pleasant breath, and medications such as nicotine additive as a means for helping to stop the smoking habit. There are also complex devices, as described below, that permit very precise slow release of drugs within the body. My invention fits into the wide gap between the very simple chewing gum and the complex drug delivery devices. My invention is a novel family of low cost disposable devices, which provide the slow release of substances within the mouth, as a convenient means to satisfy this need. My invention involves a novel combination of materials and designs.
2. Description of Prior Art
Prior art in this field discloses that there has been a great deal of industrial research that is directed toward the development of controlled release or slow release of substances or drugs within the body of humans and animals. Typical efforts in this field were printed in a recent publication of the American Chemical Society, Polymer Preprints of Papers presented at the Anaheim, Calif. Meeting in March 1999. A paper on page 253 was titled, FEASIBILTY ASSESSMENT AND RAPID DEVELOPMENT OF ORAL CONTROLLED RELEASE PROTOTYPES, by Avimesh G. Thombre, Pfizer Central Research. This paper's "focus is on the factors that should be considered in the feasibility assessment and strategies that can be employed to rapidly progress prototype oral controlled release dosage forms to clinical evaluation". This paper does not describe any device for controlled release of a drug. In the same publication, there is a paper, page 256, entitled, STRATEGIES OF ORAL DRUG DELIVERY, by Vincent H. L. Lee, University of Southern California. This paper states that, "The time is ripe for the development of innovative drug delivery systems. " The author discusses the interplay of polymer chemistry and cell biology as a means for the development of oral drug delivery systems, but does not mention any device that may be useful for this type of application. In the same publication, pages 322-323, there is a paper entitled, "SOLUBILITY CONSIDERATIONS AND DESIGN OF CONTROLLED RELEASE DOSAGE FORMS, by G. M. Venkatesh, SB Pharmaceuticals, Collegeville, Pa. This paper describes" four different approaches for developing controlled release dosage forms for bioactive materials . . . " The paper does not refer to any simple disposable device, such as my invention, that could be used for this type of application.
I anticipate that my invention of a relatively simple device for slow delivery of substances into the oral cavity will be a significant contribution to this field, even though my invention will not be suited for many stringent applications where very high precision in the rate of release is desirable or necessary.
An important point to repeat and emphasize is that prior art devices for the slow release of substances, have been either simple chewing gums/lozenges or complex and expensive devices, so that my invention is an innovative and nonobvious device for this type of application. My devices do not have the many drawbacks of chewing gums, which include an unfavorable user appearance due to factors such as the visible chewing action or the large bulge of gum that is usually apparent as a protruding spot along the lips. Also, the chewing action is tiresome for the user, and the loose gum within the mouth makes it awkward to speak in a normal manner or tone. Lozenges provide a relatively fast release of a substance and, during use, cause an interference with normal speech. My devices are secured in a stationary position within the mouth, and designed so that they are not obvious to observe and the user can become accustomed to its use so that speaking is not significantly hindered.
Pertinent patents related to slow release technology are the following U.S. Pat. Nos.:
4,206,757; 4,627,852; 5,205,820; 5,368,570; 5,413,572; 5,419,771; 5,649,910; and 5.656,032.
U.S. Pat. No. 4,206,757 is titled, DEVICE FOR THE ADMINISTRATION OF MEDICINAL SUBSTANCES, and involves a medical substance in a flexible cup, which is pressed against a subject's ear skin by a pin passing through the cup and ear. U.S. Pat. No. 4,627,852 is titled ACTIVE COMPOUND RELEASE SYSTEMS, and "relates to a system for the release of active compounds to the skin over a prolonged period, in particular to antiphlogistic medical plasters." U.S. Pat. No. 5,649,910 is titled FLUID DELIVERY APPARATUS AND METHOD OF MAKING SAME, and relates to a complex apparatus, which includes a visual flow indicator, for "infusing medical agents into an ambulatory patient at specific rates over extended periods of time." This cited patent will deliver fluids to a patient in precise quantities and "at extended microfusion rates overtime." U.S. Pat. Nos. 5,205,820; 5,368,570; 5,419,771 and 5,656,032 relate to apparatus and methods for accurately infusing fluid s into a patient at specific rates over an extended period of time.